DETAILED ACTION
This office action is responsive to the amendment filed 6/30/2026. As directed, claims 13, 14, and 20 have been amended, claim 2 has been canceled, and no claims have been added. Thus claims 1 and 3-21 are currently pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/30/2026 has been entered.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 14-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flynn (2009/0260628).
Regarding claim 14, Flynn discloses a nebulizer (figs. 6, 10, 12) comprising a nebulizer housing (i.e. 680, 1280), a patient interface (212), an ambient air infeed (954) for carrying inhaled air to the nebulizer for entraining a medication for administration to a patient’s lungs ([0088] last 20 lines), an exhaled air outfeed (921) for carrying exhaled air from the lungs through the exhaled air outfeed (921) to be treated or contained where the exhaled air may carry contagions entrained therein and could enter the contagions into the environment if not prevented ([0086] lines 1-6 disclose filtering the exhaled air), a disinfecting chamber (270, 964) attached to the nebulizer for reducing the amount of contagions entering the environment from the exhaled air outfeed ([0086] lines 1-6, [0104] lines 1-10); and an ambient air T splitter device (214, 914) that separates inhaled air from exhaled air (as shown, the connector includes valves that at least partially separate air flows), the T splitter (214, 964) configured to control directional flow of air (as shown, the connector includes valves that at least partially separate air flows) so that air can only flow in through the ambient air infeed (954) and air can only flow out of the exhaled air outfeed (921) ([0088] lines 1-10, [0085] lines 1-10 disclose the valves are one way valves), and wherein the T splitter device (214, 914) in configured to be attached to the nebulizer housing ([0089] lines 1-6).
Regarding claim 15, Flynn discloses the device (214, 914) is a T-splitter (as shown the connector is a T shaped connector).
Regarding claim 16, Flynn discloses the device comprises at least two one-way valves (950, 940, 930; [0084] lines 1-5, [0085] lines 1-5, [0088] lines 1-3).
Regarding claim 17, Flynn discloses the device (214, 914) is positioned between the patient interface (212, 912) and the nebulizer (680, 1280).
Regarding claim 18, Flynn discloses the device (214, 914) is positioned for communication with the exhaled air outfeed (fig. 9 shows flow arrows in fluid communication).
Regarding claim 19, Flynn discloses the device (214, 914) is attached to the exhaled air outfeed (921).
Regarding claim 20, Flynn discloses device (214, 914) for removably attaching to a nebulizer that has nebulizer housing(i.e. 680, 1280), a patient interface (212, 912), an ambient air infeed (954) for carrying inhaled air to the nebulizer for entraining a medication for administration to a patient’s lungs ([0088] last 20 lines), an exhaled air outfeed (921) for carrying exhaled air from the lungs through the exhaled air outfeed (921) to be treated or contained where the exhaled air may carry contagions entrained therein and could enter the contagions into the environment if not prevented ([0086] lines 1-6 disclose filtering the exhaled air), wherein the device (214, 914) is an ambient air T-splitter (as shown the connector is a T shaped connector) and comprises at least two one-way valves (950, 940, 930; [0084] lines 1-5, [0085] lines 1-5, [0088] lines 1-3) to control directional flow of air (as shown, the connector includes valves that at least partially separate air flows) so that air can only flow in through the ambient air infeed (954) and air can only flow out of the exhaled air outfeed (921) ([0088] lines 1-10, [0085] lines 1-10 disclose the valves are one way valves), and wherein the T splitter device (214, 914), the device (214, 914) is positioned between the patient interface (212, 912) and the nebulizer (680, 1280) and positioned for communication with the exhaled air outfeed (fig. 9 shows flow arrows in fluid communication) being attached to the exhaled air outfeed (921).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-13, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flynn (2009/0260628) in view of LeMahieu (2008/0066739).
Regarding claim 1, Flynn discloses a nebulizer (figs. 6, 10, 12) having a nebulizer housing (i.e. 680, 1280), a patient interface (212), an ambient air infeed (954) for carrying inhaled air to the nebulizer for entraining a medication for administration to a patient’s lungs ([0088] last 20 lines), and an exhaled air outfeed (921) for carrying exhaled air from the lungs through the exhaled air outfeed (921) to be treated or contained where the exhaled air may carry contagions entrained therein and could enter the contagions into the environment if not prevented ([0086] lines 1-6 disclose filtering the exhaled air), the improvement comprising a disinfecting chamber (270, 964) attached to the nebulizer for reducing the amount of contagions entering the environment from the exhaled air outfeed ([0086] lines 1-6, [0104] lines 1-10).
Flynn discloses the disinfecting chamber (i.e. 270, 964) including a tube (272,274) around where exhaled air exits the chamber (i.e. via port 265) is removably attached to the nebulizer housing ([0066] lines 1-10, [0082] lines 13-20, [0073] lines 1-5 disclose the filter and nebulizer are detachably connected) and use of a filter for filtering bacteria and viruses ([0106 last 10 lines) but does not specifically disclose the disinfecting chamber comprises a UVC light source capable of reducing the amount of contagions. However, LeMahieu teaches the disinfecting chamber comprises a UVC light source capable of reducing the number of contagions ([0144] last 10 lines). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the disinfecting chamber of Flynn with UV sterilization as taught y LeMahieu to provide the advantage of enhanced destruction of RNA or DNA of airborne pathogens as disclosed by LeMahieu in [0144] last 5 lines.
Regarding claim 3, Flynn discloses the disinfecting chamber (270, 964) is designed to create a cyclone flow pattern for exhaled air flowing through the disinfecting chamber (i.e. as shown, the chamber is cylindrical with annular walls thereby able to create a cyclone pattern at least against the walls).
Regarding claim 4, Flynn discloses the disinfecting chamber (i.e. 270, 964) is removably attached to the nebulizer housing ([0066] lines 1-10, [0082] lines 13-20, [0073] lines 1-5 disclose the filter and nebulizer are detachably connected).
Regarding claim 5, Flynn discloses the disinfecting chamber comprises a filter (276, 948) capable of reducing the amount of contagions.
Regarding claim 6, Flynn discloses a device (214, 914) that separates inhaled air from exhaled air (as shown, the connector includes valves that at least partially separate air flows).
Regarding claim 7, Flynn discloses wherein the device (214, 914) is removably attachable to the nebulizer housing ([0082] lines 13-20, [0073] lines 1-5 disclose the connector and nebulizer are detachably connected).
Regarding claim 8, Flynn discloses the device (214, 914) is a T-splitter (as shown the connector is a T shaped connector).
Regarding claim 9, Flynn discloses the device comprises at least two one-way valves (950, 940, 930; [0084] lines 1-5, [0085] lines 1-5, [0088] lines 1-3).
Regarding claim 10, Flynn discloses the device (214, 914) is positioned between the patient interface (212, 912) and the nebulizer (680, 1280).
Regarding claim 11, Flynn discloses the device (214, 914) is positioned for communication with the exhaled air outfeed (fig. 9 shows flow arrows in fluid communication).
Regarding claim 12, Flynn discloses the device (214, 914) is attached to the exhaled air outfeed (921).
Regarding claim 13, Flynn discloses a nebulizer (figs. 6, 10, 12) comprising a nebulizer housing (i.e. 680, 1280), a patient interface (212), an ambient air infeed (954) for carrying inhaled air to the nebulizer for entraining a medication for administration to a patient’s lungs ([0088] last 20 lines), an exhaled air outfeed (921) for carrying exhaled air from the lungs through the exhaled air outfeed (921) to be treated or contained where the exhaled air may carry contagions entrained therein and could enter the contagions into the environment if not prevented ([0086] lines 1-6 disclose filtering the exhaled air), and a disinfecting chamber (270, 964) attached to the nebulizer for reducing the amount of contagions entering the environment from the exhaled air outfeed ([0086] lines 1-6, [0104] lines 1-10).
Flynn discloses the disinfecting chamber (i.e. 270, 964) which produces no back pressure on the nebulizer (as shown, the chamber connects via friction fit and thus does not create back pressure or push back on the chamber, i.e. no mechanical push member is present); the disinfecting chamber (i.e. 270, 964) including a tube (272,274) positioned around where exhaled air exits the chamber (i.e. via port 265) is removably attached to the nebulizer housing ([0066] lines 1-10, [0082] lines 13-20, [0073] lines 1-5 disclose the filter and nebulizer are detachably connected) and use of a filter for filtering bacteria and viruses ([0106 last 10 lines) but does not specifically disclose the disinfecting chamber comprises a UVC light source capable of reducing the amount of contagions. However, LeMahieu teaches the disinfecting chamber comprises a UVC light source capable of reducing the number of contagions ([0144] last 10 lines). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the disinfecting chamber of Flynn with UV sterilization as taught by LeMahieu to provide the advantage of enhanced destruction of RNA or DNA of airborne pathogens as disclosed by LeMahieu in [0144] last 5 lines.
Regarding claim 21, Flynn discloses the disinfecting chamber (i.e. 270, 964) which produces no back pressure on the nebulizer (as shown, the chamber connects via friction fit and thus does not create back pressure or push back on the chamber, i.e. no mechanical push member is present).
Response to Arguments
Applicant's arguments filed 6/30/2026 have been fully considered but they are not persuasive.
Applicant argues on page 6 last paragraph that Flynn does not disclose controlling directional airflow. Examiner respectfully disagrees. Flynn discloses the connector includes valves that at least partially separate air flows so that air can only flow in through the ambient air infeed (954) and air can only flow out of the exhaled air outfeed (921) ([0088] lines 1-10, [0085] lines 1-10 disclose the valves are one way valves), Thus Flynn teaches this limitation as claimed.
Applicant argues on page 7 1st paragraph that valve 950, 954 does not carry inhalation air to the nebulizer for entraining medication. Examiner respectfully disagrees. As shown with the directional arrows in fig. 9 of Flynn, when fluid flow is less than inspiratory effort, air for inhalation enters through one way valve 954, travels to the top of the nebulizer where medication vapor is mixed with the air, and travels up to the patient interface ([0088]). Thus Flynn teaches this limitation as claimed.
Applicant argues on page 8 2nd paragraph that LeMahieu does not teach UV light around the exhalation tube. Examiner respectfully disagrees as Flynn discloses a filtering tube (272,274) positioned around where exhaled air exits the chamber (i.e. via port 265). LeMahieu teaches the disinfecting chamber comprises a UVC light source capable of reducing the number of contagions ([0144] last 10 lines). One of ordinary skill in the art upon seeing the UV light disinfection of LeMahieu would recognize that providing the filtering tube positioned around the exhalation tube of Flynn with a UV light disinfection source as taught by LeMahieu such that the UV light would also be positioned around the tube would provide the advantage of enhanced filtering and disinfection. Thus the combination of Flynn and LeMahieu teach these limitations as claimed.
Applicant argues on page 9 2nd and last paragraph that Flynn creates pneumatic back pressure with a filter. However, Examiner notes that the claim language recites “the disinfecting chamber produces no back pressure” and does not recite or include the role of a filter. In addition, the claim language does not specify or differentiate between pneumatic or mechanical back pressure. The claim language merely recites a functional limitation without requiring any corresponding structure required to perform the function. Thus Flynn discloses the disinfecting chamber (i.e. 270, 964) which produces no back pressure on the nebulizer (as shown, the chamber connects via friction fit and thus does not create back pressure or push back on the chamber, i.e. no mechanical push member is present). Thus Flynn teaches this limitation as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LATOYA M LOUIS whose telephone number is (571)270-5337. The examiner can normally be reached M-F 1 pm - 6:30 pm ET.
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/LaToya M Louis/Primary Examiner, Art Unit 3785
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